CIP IRB Administration & Management 3 — Questions and Answers
Question 1: An IRB operating under a Federalwide Assurance (FWA) must ensure that all covered research conducted at the institution is reviewed by an IRB. Who is ultimately responsible for the FWA commitments?
- The principal investigator of each study
- The IRB Chair
- The institutional official (IO) (Correct answer)
- The OHRP regional representative
Correct answer: The institutional official (IO)
The institutional official (IO) signs the FWA and bears ultimate institutional responsibility for compliance with its commitments to OHRP.
Question 2: Which of the following changes to an approved protocol requires only an administrative review rather than full-board review?
- Adding a new investigational drug arm
- Extending enrollment to a new vulnerable population
- Updating the PI's contact phone number (Correct answer)
- Increasing the maximum radiation dose
Correct answer: Updating the PI's contact phone number
Changes that are purely administrative (e.g., updating contact information) and do not affect the rights, safety, or welfare of participants do not require full-board review.
Question 3: Under the Common Rule, research conducted in established or commonly accepted educational settings involving normal educational practices is:
- Exempt under Category 1 only if student data are de-identified
- Eligible for expedited review but not exemption
- Exempt under Category 1 regardless of whether data are identifiable (Correct answer)
- Subject to full-board review due to the involvement of minors
Correct answer: Exempt under Category 1 regardless of whether data are identifiable
45 CFR 46.104(d)(1) (Category 1 exemption) covers normal educational practices research in educational settings and does not restrict exemption based on identifiability.
Question 4: A protocol involves a survey about alcohol use among college students. The IRB is concerned about the risk of mandatory reporting if a student discloses illegal underage drinking. The best protective measure is to:
- Exclude all participants under age 21 to eliminate the issue
- Obtain a Certificate of Confidentiality to protect identifiable research information from compelled disclosure (Correct answer)
- Collect data anonymously and destroy records immediately after collection
- Require participants to sign a waiver releasing the researcher from reporting obligations
Correct answer: Obtain a Certificate of Confidentiality to protect identifiable research information from compelled disclosure
A Certificate of Confidentiality (CoC) legally protects identifiable research data from compelled disclosure in legal, administrative, or other proceedings.
Question 5: During a convened IRB meeting, a member discloses a financial conflict of interest with a study on the agenda. The correct procedure is to:
- Allow the member to participate in discussion but not vote
- Require the member to leave the room for both discussion and vote on that study (Correct answer)
- Permit normal participation because disclosure alone satisfies conflict rules
- Replace the member temporarily with an alternate for the entire meeting
Correct answer: Require the member to leave the room for both discussion and vote on that study
IRB members with a conflicting interest must recuse themselves from both deliberation and voting on the affected study, typically by leaving the room.
Question 6: A sponsor-initiated protocol modification would increase participant burden by adding two extra clinic visits. Before implementing the change, the research team must:
- Notify participants verbally and proceed if they agree
- Submit an amendment for IRB review and receive approval before implementing (Correct answer)
- Implement the change and report it at the next continuing review
- Report the change to the FDA and wait 30 days for clearance
Correct answer: Submit an amendment for IRB review and receive approval before implementing
Any modification that increases participant burden must be approved by the IRB before implementation, as it may affect participant welfare and consent.
Question 7: Which element of a HIPAA Authorization is NOT required when research involves protected health information (PHI)?
- A description of the PHI to be used or disclosed
- The name or class of persons authorized to make the disclosure
- The participant's Social Security Number (Correct answer)
- An expiration date or expiration event
Correct answer: The participant's Social Security Number
HIPAA Authorizations do not require a Social Security Number; required elements include description of PHI, authorized persons, expiration, and the individual's right to revoke.
CIP IRB Administration & Management 3
An IRB operating under a Federalwide Assurance (FWA) must ensure that all covered research conducted at the institution is reviewed by an IRB.
Who is ultimately responsible for the FWA commitments?